Iron Deficiency Anemia in ChildbirthNCT06283342
Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency
An observational study of Iron Deficiency Anemia in Childbirth and Infant Nutrition Disorders, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Iron Deficiency Anemia in Childbirth, Infant Nutrition Disorders, Iron Deficiencies
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Child
Study population: Study population include children aged 6-24 months, who were admitted to the general pediatric outpatient clinic of our hospital between January 1st, 2018, and February 1st, 2019.
Who may be able to join
- Patients aged between 6-24 months and admitted to the general pediatrics outpatient clinic
Who cannot join
- Chronic disease
- Blood transfusion history,
- Thalassemia carrier status
- Clinical diagnosis of infection or elevated C-reactive protein (CRP)
- Patients who received iron deficiency or iron deficiency anemia treatment
- Those who were born prematurely
- Patients with low birth weight
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: The Role of Prophylactic Iron Use and Nutrition in Preventing Iron Deficiency in Infancy
This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy.
Read the detailed description
Iron plays an important role in oxidation and reduction reactions, which have a very important place in the continuation of life. Iron plays an essential role in these reactions because it can easily gain and lose electrons in redox reactions. Iron is mostly found in the heme molecule in organisms. However, iron has structural and functional importance for many enzymes and proteins other than heme. Iron deficiency (ID) is the most common nutritional deficiency in children worldwide. ID is more common in socio-economically developing geographies. However, it is still an important problem in developed countries. A plasma ferritin level below 12 mg/L is defined as ID, which is often used synonymously with iron deficiency anemia (IDA). However, ID develops before anemia occurs. Weakness, fatigue, tiring quickly, insomnia, and regression in neuro-cognitive functions may occur in ID that precedes the signs of anemia. With the development of anemia, the clinical diagnosis of IDA is fully revealed.
In ID that occurs in infancy, psychomotor development is adversely affected, and the development of cognitive functions slows down or even stops. Immune system functions regress. Although iron treatment can reverse these negative effects, some effects are permanent. Therefore, prevention of ID is more important than treatment. In addition, it is easier and cheaper to prevent ID and IDA than to treat them. It is a health policy to recommend iron prophylaxis to children aged 4-12 months in the Republic of Turkey.
Adding iron-rich foods to the diet, adequate breast milk intake, and prophylaxis with iron preparations can be used to prevent ID and IDA. However, there are different data in the literature on the use of prophylactic iron preparations.
- Keywords
- prophylactic iron, infant nutrition, iron deficiency prevention, pediatric health
- Medical subject headings
- Infant Nutrition Disorders, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency group | Patients with a ferritin level below 12 mg/L were considered to have Iron deficiency group. | |
| Not iron deficiency group | Patients with a ferritin level above 12 mg/L were considered to have not iron deficiency group. | |
| Iron deficiency anemia group | Patients with ferritin level below 12 mg/L and hemoglobin (Hb) value below 11 g/dL were considered to have IDA. | |
| Not iron deficiency anemia group | Patients with ferritin level below 12 mg/L and hemoglobin (Hb) value above 11 g/dL were considered to have Not iron deficiency anemia group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritine level
Ferritin level below 12 mg/L was considered iron deficiency.
Measured: day 1
Secondary outcomes (4)
Hemoglobin level
Hemoglobin (Hb) values below 11 g/dL were considered as having anemia
Measured: day 1
Prophylactic iron use rate
Giving 10 mg/day iron drops to babies starting from the 4th month was considered as the correct prophylaxis recommendation. Prophylactic iron use rates were calculated by dividing those using iron prophylaxis in all groups by the number of participants in the groups.
Measured: 15 days
Iron-sufficient supplementary food intake rate of babies
Babies whose mothers answered "yes" to at least two of the following questions in the survey evaluating babies' iron-sufficient supplementary food intake were considered to be fed adequately in terms of iron:
- Does your baby eat 1 egg at least 3 days a week?
- Does your baby eat meat the size of 2 meatballs 2 days a week?
- Does your baby eat legumes at least 3 times a week? This ratio was calculated by dividing the number of adequately nourished participants by the total number of participants in the group.
Measured: 15 days
Breast milk usage rate
Exclusive breastfeeding for at least 6 months after birth was considered adequate breast milk intake. Those who breastfed during this period were considered to have used sufficient breast milk. The breast milk usage rate was found by dividing those who received adequate breast milk by the participants in the group.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia in ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283342
- Sponsor's protocol ID
- Konya Pediatric Hematology
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data (IPD) available to other researchers
Publications
Simsek A, Energin VM. The role of prophylactic iron utilization and nutrition to prevent iron deficiency in infancy: Prospective cohort study. Medicine (Baltimore). 2025 Jun 13;104(24):e42947. doi: 10.1097/MD.0000000000042947.
PubMed 40527768
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Prophylactic Iron Use and Nutrition in Preventing Iron Deficiency in Infancy
- ClinicalTrials.gov ID
- NCT06283342
- Acronym / sponsor ID
- Konya Pediatric Hematology
- Keywords
- prophylactic iron, infant nutrition, iron deficiency prevention, pediatric health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy.
Detailed description
Iron plays an important role in oxidation and reduction reactions, which have a very important place in the continuation of life. Iron plays an essential role in these reactions because it can easily gain and lose electrons in redox reactions. Iron is mostly found in the heme molecule in organisms. However, iron has structural and functional importance for many enzymes and proteins other than heme. Iron deficiency (ID) is the most common nutritional deficiency in children worldwide. ID is more common in socio-economically developing geographies. However, it is still an important problem in developed countries. A plasma ferritin level below 12 mg/L is defined as ID, which is often used synonymously with iron deficiency anemia (IDA). However, ID develops before anemia occurs. Weakness, fatigue, tiring quickly, insomnia, and regression in neuro-cognitive functions may occur in ID that precedes the signs of anemia. With the development of anemia, the clinical diagnosis of IDA is fully revealed.
In ID that occurs in infancy, psychomotor development is adversely affected, and the development of cognitive functions slows down or even stops. Immune system functions regress. Although iron treatment can reverse these negative effects, some effects are permanent. Therefore, prevention of ID is more important than treatment. In addition, it is easier and cheaper to prevent ID and IDA than to treat them. It is a health policy to recommend iron prophylaxis to children aged 4-12 months in the Republic of Turkey.
Adding iron-rich foods to the diet, adequate breast milk intake, and prophylaxis with iron preparations can be used to prevent ID and IDA. However, there are different data in the literature on the use of prophylactic iron preparations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency group | – | –Patients with a ferritin level below 12 mg/L were considered to have Iron deficiency group. |
| Not iron deficiency group | – | –Patients with a ferritin level above 12 mg/L were considered to have not iron deficiency group. |
| Iron deficiency anemia group | – | –Patients with ferritin level below 12 mg/L and hemoglobin (Hb) value below 11 g/dL were considered to have IDA. |
| Not iron deficiency anemia group | – | –Patients with ferritin level below 12 mg/L and hemoglobin (Hb) value above 11 g/dL were considered to have Not iron deficiency anemia group. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Study population include children aged 6-24 months, who were admitted to the general pediatric outpatient clinic of our hospital between January 1st, 2018, and February 1st, 2019.
Key inclusion criteria (1 listed)
- Patients aged between 6-24 months and admitted to the general pediatrics outpatient clinic
Key exclusion criteria (7 listed)
- Chronic disease
- Blood transfusion history,
- Thalassemia carrier status
- Clinical diagnosis of infection or elevated C-reactive protein (CRP)
- Patients who received iron deficiency or iron deficiency anemia treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ferritine level
Time frame: day 1
Ferritin level below 12 mg/L was considered iron deficiency.
4 secondary outcomes
Hemoglobin level
Time frame: day 1
Prophylactic iron use rate
Time frame: 15 days
Iron-sufficient supplementary food intake rate of babies
Time frame: 15 days
Breast milk usage rate
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40527768Simsek A, Energin VM. The role of prophylactic iron utilization and nutrition to prevent iron deficiency in infancy: Prospective cohort study. Medicine (Baltimore). 2025 Jun 13;104(24):e42947. doi: 10.1097/MD.0000000000042947.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia in Childbirth and Infant Nutrition Disorders, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritine level (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.